FDA UDI
In Commercial Distribution
🇺🇸 United States
GM501 Gradient 100%
DI: 00858604006221
·
Model: 4GM501G-100-100
·
HAMILTON THORNE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- GM501 Gradient 100%
- Primary DI
- 00858604006221
- Version / Model
- 4GM501G-100-100
- Company Name
- HAMILTON THORNE, INC.
- Labeler DUNS
- 152161337
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-30
- Public Version
- 1
- Public Version Date
- 2021-05-10
- Public Version Status
- New
- Public Device Record Key
- 9bea3cbd-78a1-42f6-ba0b-dd6a8e38470e
Device Description
GM501 Gradient 100% is a stock solution for semen preparation. It is a ready-to-use isotonic gradient for semen preparation with a density of approximately 1.12g/ml. GM501 Gradient 100% can be used in combination with IUI, IVF, and ICSI procedures.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- Yes
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MQL | Media, Reproductive | Obstetrics/Gynecology | 884.6180 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41427 | Cell centrifugation/density gradient separation reagent IVD | A substance or reactant intended to be used for the isolation of cells from a clinical specimen (e.g., lymphocytes from whole blood, cells from a liquid-based cytology specimen) using centrifugation and density gradient to achieve specimen component separation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00858604006221 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K053494 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius